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Gut bacteria in a capsule: a new attempt to calm a brain complication of cirrhosis

NCT ID NCT06368895

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers test whether fecal microbiota transplantation delivered by oral capsules can help cirrhosis patients whose hepatic encephalopathy no longer responds to standard lactulose and rifaximin. The trial enrolls 33 adults with cirrhosis and persistent or recurrent hepatic encephalopathy. Participants are split into three groups: one receives transplant by colonoscopy plus capsules, one receives capsules only, and one continues standard therapy alone. The study tracks safety, mental function, gut bacteria, inflammation, and metabolic changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fecal microbiota transplantation delivered by oral capsules
What this could lead to
If it works, this could offer a capsule-based way to ease hepatic encephalopathy in cirrhosis patients who no longer respond to standard lactulose and rifaximin therapy.
What could go wrong
This is an early-phase trial with 33 participants, so results may not hold in larger groups. Fecal transplants carry risks of infection and digestive side effects, and the capsules may not change brain symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

33 people

The number who actually took part.

Started

Apr 2021

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of liver cirrhosis * Hepatic encephalopathy of grade \>1 or higher according to West Haven classification, persistent or recurrent despite treatment with lactulose/lactitol and rifaximin at adequate doses started at least 30 days before the Hepatic encephalopathy episode Exclusion Criteria: * Na \<130 meq /l * Creatinine \> 1.3 mg / dl * Presence of grade 3 ascites * Presence of esophagogastric varices at risk of haemorrhage in the absence of adequate prophylaxis * Presence of other possible causes of encephalopathy (cerebral vascular disease, known neurodegenerative or cognitive disorders) * Known psychiatric disorders or other causes of brain dysfunction (e.g. hypoglycemia, hyponatremia) * Alcohol consumption * Diagnosis of hepatocellular carcinoma * Contraindication to fecal microbiota transplantation (e.g. pregnancy or breastfeeding) * Presence of known intestinal diseases * Any clinical condition that, in the opinion of the investigators, may contraindicate the enrollment in the study

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Dysbiosis hepatic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysbiosis Hepatic encephalopathy

Contacts and locations

Locations

  • Fondazione Policlinico Agostino Gemelli IRCCS

    Rome, 00168, Italy

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